Medicine
Rowasa 4 g/60 mL rectal suspension
Rowasa 4 g/60 mL rectal suspension is a prescription medicine containing Mesalamine for rectal use, marketed by Viatris Specialty, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at controlled room temperature 20°C to 25°C (68°F to 77°F), Excursions…
Key facts
- Active ingredient (INN)
- Mesalamine
- Brand
- Rowasa
- Strength
- 4 g/60 mL
- Dosage form
- Rectal suspension
- Route
- Rectal
- Packs
- 28 bottles, 7 bottles
- Marketing authorisation holder
- Viatris Specialty
- Manufacturer
- Viatris Specialty
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20°C to 25°C (68°F to 77°F), Excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EC02 Mesalamine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 March 2016
- Identifiers
- RxCUI 206798, 238151DailyMed set ID e505ab99-1943-4216-a178-4d5dbe64e3b2NDC 0037-0066Application NDA019618
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 28 bottle, dispensing in 1 carton / 60 mL in 1 bottle, dispensing | 0037-0066-03 | Viatris Specialty | 24 March 2016 |
| 7 bottle, dispensing in 1 carton / 60 mL in 1 bottle, dispensing | 0037-0066-05 | Viatris Specialty | 24 March 2016 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 December 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Mesalamine 4 g/60 mL rectal suspension.
Other strengths and forms of Mesalamine
Clinical summary
Mesalamine is an aminosalicylate indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. It is available as delayed-release tablets, extended-release capsules and suppositories for oral and rectal use. MedsAcross supplies Mesalamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MesalamineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rowasa prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Rowasa 4 g/60 mL rectal suspension for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.